Personalized Treatment for Refractory H Pylori Infection

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: rabeprazole+bismuth+2 antibiotics; Drug: rabeprazole+3 antibiotics; Drug: rabeprazole+amox+tetr+levo

• Registration Number: NCT02547025
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

In this study, the investigators develop a personalized treatment according to culture-guided antibiotics plus high-dose proton-pump inhibitor and bismuth to treat refractory H pylori infection.

Detailed Description

They are categorized into three groups: (1) patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics), (2) patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics), and (3) patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.

Study Timeline

• Study Start: 2012-08-01
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

H pylori-infected adult patients with at least two previous failed eradication attempts will be enrolled in this study after giving informed consent.

• positive results of both rapid urease test and histology,
• a positive result of Urea breath test,
• or a positive result of culture

Exclusion Criteria

• ingestion of antibiotics, bismuth, or proton-pump inhibitor within the prior 4 weeks,
• patients with allergic history to the medications used,
• patients with previous gastric surgery,
• the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
• pregnant women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rabeprazole+bismuth+2 antibiotics	rabeprazole+bismuth+2 antibiotics	patients who have positive result of culture with one or two susceptible antibiotics are treated by bismuth-containing therapy (rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days
rabeprazole+3 antibiotics	rabeprazole+3 antibiotics	patients who have positive result of culture with equal to or more than three susceptible antibiotics are treated by non-bismuth quadruple therapy (rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days
rabeprazole+amox+tetr+levo	rabeprazole+amox+tetr+levo	patients who have negative result of culture or whose culture data are unavailable will be treated by (rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days

Primary Outcome Measures

Name	Time	Method
Number of Participants in Which H. Pylori Was Eradicated	eight weeks after the end of anti-H pylori therapy	To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan